FDA Commissioner Marty Makary called these changes “common-sense reforms” that could expedite the development of cell and ...

FDA announces wearable devices providing non-medical info won't face regulation, offering clarity on digital health ...

The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general ...

The Food and Drug Administration today released two guidance documents; one related to low-risk wellness products (including ...

The FDA has been called out for its refusal to ban formaldehyde in hair straightening products, jeopardizing the health of ...

Three key themes emerged across the mifepristone documents: consistent safety findings, lack of ideological bias in staff ...

The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches to improve ...

FDA proposes framework clinical trial designs to guide Bayesian methods, improving efficiency in drug development for rare and pediatric conditions.

The Senate Health, Education, Labor, and Pensions Committee, chaired by Sen. Bill Cassidy, R-Louisiana, held a hearing about ...

The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration's new fast-track program after agency scientists flagged safety and efficacy concerns, ...

Owlet, Inc. OWLT is benefiting from increased regulatory clarity in the infant monitoring market, a factor that may strengthen its competitive positioning over time. As safety and accuracy gain ...